DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 21 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hashimoto et al. (US 2020/0072732 A1; hereinafter “Hashimoto”).
Regarding claim 1, Hashimoto teaches a biological particle sorting device (microchip 100; figure 1; paragraphs 54 – 62) comprising:
a pressure changing element (a pressure chamber that can contain a piezo element in communication with particle fractionating flow path 109; paragraphs 61 – 63 and 84) that changes a pressure in a channel (particle fractionating flow path 109) in which a biological particle determined to be sorted is recovered (via the detection unit; paragraphs 164 – 167); and
a control unit (a control unit which is a programmed controller; paragraphs 121, 151 and 152) that drives the pressure changing element,
wherein the control unit adjusts a drive waveform (adjusting the driving voltage corresponds to adjusting the driving waveform as indicated in paragraph 84) of the pressure changing element on a basis of information associated with a number of times of sorting processing per unit time or information associated with a percentage or a number of sorting target particles contained in a unit sample (the number of fractionated or sorted particles are counted and this information is utilized to determine when suctioning or sorting is performed; figure 7; paragraph 114).
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Regarding apparatus claims 1 – 20, the cited prior art teaches all of the positively recited structure of the claimed apparatus. The recitation of a new intended use, for an old product, does not make a claim to that old product patentable. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987).
Claims 1 – 20 do not use “programmed to” language to positively recite that the claimed device is used to perform a particular process or function according to specific instructions from program software (see MPEP section 2100, page 2100-14). The claimed apparatus structure still does not exclude the prior art apparatus structure, even though it may operate in a different manner. The Court has held that programming creates a new machine because a general purpose computer in effect becomes a special purpose computer once it is programmed to perform particular functions pursuant to instructions from program software. See In re Alappat, 31 USPQ2d 1545 (1994) (see MPEP § 2106).
Examiner recommends the use of “configured to” or “programmed to” language for indicating that a limitation is specifically structurally designed and/or programmed, respectively, to perform the recited associated function in order to delineate the claimed apparatus from the prior art.
Regarding claim 2, Hashimoto teaches the biological particle sorting device according to claim 1, wherein the control unit adjusts a drive time (e.g., paragraphs 64 and 79 – 83), a drive voltage (adjusting the driving voltage corresponds to adjusting the driving waveform as indicated in paragraph 84), or both the drive time and the drive voltage among elements of the drive waveform (adjusting the driving voltage corresponds to adjusting the driving waveform as indicated in paragraph 84).
Regarding claim 3, Hashimoto does not specifically teach the biological particle sorting device according to claim 2, wherein, in a case where the number of times of sorting processing is equal to or more than a predetermined value, the drive time is increased, the drive voltage is lowered, or both the increase of the drive time and the lowering of the drive voltage are executed. However, as indicated above, Hashimoto teaches all of the positively recited structure of the apparatus as claimed, and is therefore considered capable of being operated in the intended manner.
Regarding claim 4, Hashimoto does not specifically teach the biological particle sorting device according to claim 1, wherein the number of times of sorting processing is a counted number of times of sorting processing or an estimated number of times of sorting processing. However, as indicated above, Hashimoto teaches all of the positively recited structure of the apparatus as claimed, and is therefore considered capable of being operated in the intended manner.
Regarding claim 5, Hashimoto does not specifically teach the biological particle sorting device according to claim 1, wherein the number of times of sorting processing is a number of times the pressure changing element is driven per unit time. However, as indicated above, Hashimoto teaches all of the positively recited structure of the apparatus as claimed, and is therefore considered capable of being operated in the intended manner.
Regarding claim 6, Hashimoto does not specifically teach the biological particle sorting device according to claim 1, wherein the number of times of sorting processing is a number of times a determination is made to execute sorting per unit time. However, as indicated above, Hashimoto teaches all of the positively recited structure of the apparatus as claimed, and is therefore considered capable of being operated in the intended manner.
Regarding claim 7, Hashimoto does not specifically teach the biological particle sorting device according to claim 6, further comprising a determination unit that determines whether or not to sort a biological particle, wherein the control unit adjusts the drive waveform on a basis of information associated with the number of times a determination is made to execute sorting by the determination unit. However, as indicated above, Hashimoto teaches all of the positively recited structure of the apparatus as claimed, and is therefore considered capable of being operated in the intended manner.
Regarding claim 8, Hashimoto teaches the biological particle sorting device according to claim 2, wherein, in a case where the percentage or the number of the sorting target particles is equal to or more than a predetermined value (e.g., a set number of microparticles can be counted and collected; paragraph 121), the control unit increases the drive time, lowers the drive voltage, or executes both the increase of the drive time and the lowering of the drive voltage (e.g., the suction force for fractionating the particles can be changed or optimized depending on the number of microparticles collected; paragraph 121; adjusting the driving voltage corresponds to adjusting the driving waveform as indicated in paragraph 84).
Regarding claim 9, Hashimoto teaches the biological particle sorting device according to claim 8, wherein the information associated with the percentage or the number of the sorting target particles is information acquired as a result of a sorting operation executed by the biological particle sorting device or information input to the biological particle sorting device (e.g., the number of microparticles counted and sorted can be considered the information associated with the number of the microparticles sorted determined by the sorting device; paragraph 121).
Regarding claim 10, Hashimoto teaches the biological particle sorting device according to claim 1, wherein the control unit (a control unit which is a programmed controller; paragraphs 121, 151 and 152) adjusts one or more of a step-up time, a step-down time, and a holding time among elements of the drive waveform (adjusting the driving voltage corresponds to adjusting the driving waveform as indicated in paragraph 84).
Regarding claim 11, Hashimoto teaches the biological particle sorting device according to claim 1, wherein, in adjusting the drive waveform (adjusting the driving voltage corresponds to adjusting the driving waveform as indicated in paragraph 84), the control unit (a control unit which is a programmed controller; paragraphs 121, 151 and 152) selects a drive waveform to be applied from among a plurality of types of drive waveforms set in advance on a basis of either the information associated with the number of times of sorting processing or the information associated with the percentage or the number of sorting target particles (e.g., paragraph 121).
Regarding claim 12, Hashimoto teaches the biological particle sorting device according to claim 1, wherein the control unit (a control unit which is a programmed controller; paragraphs 121, 151 and 152) adjusts the drive waveform (adjusting the driving voltage corresponds to adjusting the driving waveform as indicated in paragraph 84) in a sorting condition parameter adjustment step before performing a biological sample sorting processing step or in the biological sample sorting processing step (e.g., paragraph 121).
Regarding claim 13, Hashimoto teaches the biological particle sorting device according to claim 1, wherein the control unit (a control unit which is a programmed controller; paragraphs 121, 151 and 152) adjusts a drive time on a basis of the information associated with the number of times of sorting processing per unit time or the information associated with the percentage or the number of the sorting target particles contained in the unit sample, and a drive voltage set to be applied to the sorting processing (e.g., the number of microparticles counted and sorted can be considered the information associated with the number of the microparticles sorted determined by the sorting device; paragraph 121).
Regarding claim 14, Hashimoto teaches the biological particle sorting device according to claim 13, wherein the control unit (a control unit which is a programmed controller; paragraphs 121, 151 and 152) is configured to adjust the drive waveform (adjusting the driving voltage corresponds to adjusting the driving waveform as indicated in paragraph 84) in a sorting condition parameter adjustment step before performing a biological sample sorting processing step, and the control unit adjusts the drive time in the sorting condition parameter adjustment step (e.g., paragraph 121).
Regarding claim 15, Hashimoto does not specifically teach the biological particle sorting device according to claim 1, wherein in a case where the biological particle sorting device executes one sorting operation of sorting a plurality of types of sorting target particles at a predetermined ratio, the control unit adjusts a drive waveform of the pressure changing element on a basis of the information associated with the number of times of sorting processing per unit time. However, as indicated above, Hashimoto teaches all of the positively recited structure of the apparatus as claimed, and is therefore considered capable of being operated in the intended manner.
Regarding claim 16, Hashimoto does not specifically teach the biological particle sorting device according to claim 15, wherein the control unit adjusts the drive waveform in response to a change of a sorting target particle in middle of the sorting operation. However, as indicated above, Hashimoto teaches all of the positively recited structure of the apparatus as claimed, and is therefore considered capable of being operated in the intended manner.
Regarding claim 17, Hashimoto teaches the biological particle sorting device according to claim 1, the biological particle sorting device (a control unit which is a programmed controller; paragraphs 121, 151 and 152) being configured to execute a parameter adjustment step of adjusting a sorting condition parameter to be used in a biological sample sorting processing step (e.g., paragraph 121).
Regarding claim 18, Hashimoto teaches the biological particle sorting device according to claim 17, the biological particle sorting device (a control unit which is a programmed controller; paragraphs 121, 151 and 152) being configured to execute a delay time adjustment process in the parameter adjustment step (e.g., a time, which can be considered a delay time, may be determined and set for when a parameter step adjusted is desired, for example, when a suction step should be performed; paragraphs 79 and 124).
Regarding claim 19, Hashimoto does not specifically teach the biological particle sorting device according to claim 18, the biological particle sorting device being configured to measure a collection rate represented by a number of sorted particles with respect to a number of sorting operations in the delay time adjustment process. However, as indicated above, Hashimoto teaches all of the positively recited structure of the apparatus as claimed, and is therefore considered capable of being operated in the intended manner.
Regarding claim 20, Hashimoto does not specifically teach the biological particle sorting device according to claim 19, wherein, in measuring the collection rate, only in a case where no other biological particle is present within a predetermined range around a biological particle determined to be sorted, a sorting operation is executed for the biological particle. However, as indicated above, Hashimoto teaches all of the positively recited structure of the apparatus as claimed, and is therefore considered capable of being operated in the intended manner.
Regarding claim 21, Hashimoto teaches a method for adjusting a sorting condition in a biological particle sorting device, the method comprising a drive waveform adjustment step of adjusting a drive waveform (adjusting the driving voltage corresponds to adjusting the driving waveform as indicated in paragraph 84) of a pressure changing element (a pressure chamber that can contain a piezo element in communication with particle fractionating flow path 109; paragraphs 61 – 63 and 84; figure 1) that changes a pressure in a channel (fractionating flow path 109) in which a biological particle determined to be sorted is recovered, wherein, in the drive waveform adjustment step, the drive waveform of the pressure changing element is adjusted on a basis of information associated with a number of times of sorting processing per unit time or information associated with a percentage or a number of sorting target particles contained in a unit sample (the number of fractionated or sorted particles are counted and this information is utilized to determine when suctioning or sorting is performed; figure 7; paragraph 114). .
Conclusion
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796